Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD

NCT06343129 | Completed

• 1 other identifier: 3817
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education.

Conditions

Chronic Kidney Diseases

Keywords

Diet; Plant-based; Whole food; Hypertension; Hyperkalemia; Blood pressure; Potassium; Systolic blood pressure; Diastolic blood pressure

Outcome Measures

Primary Outcomes (4)

• Mean change in systolic blood pressure

  Unit of measurement - mm Hg

  Baseline to day 15

• Mean change in diastolic blood pressure

  Unit of measurement - mm Hg

  Baseline to day 15

• Mean change in potassium levels

  Unit of measurement - mEq/L

  Baseline to day 15

• Proportion of participants developing hyperkalemia

  Percentage

  Day 15

Secondary Outcomes (41)

• Mean Change in energy/day

  Baseline to day 15

• Mean change in energy/kg of body mass

  Baseline to day 15

• Mean change in total fat

  Baseline to day 15

• Mean change in % calories from fat

  Baseline to day 15

• Mean change in % calories from carbohydrates

  Baseline to day 15

Study Arms (2)

Jumpstart Educational Program

EXPERIMENTAL

Jumpstart sessions on day 1, 2, 5, 8, 12, and 15. Tests at baseline and week 2 visit: blood pressure, height and weight measurements to calculate a body mass index, urine tests to assess antioxidant activity, quality of life questionnaire (\~8 minutes to complete) about physical and mental symptoms, a 3-day food record to assess if participants are changing their diet over the course of the study, assessment of medication use. Tests performed at day 1, day 8, and day 15: A small blood draw \[about 1 teaspoon\] to check chemistry levels, cholesterol, and markers of inflammation. Laboratory tests are reviewed once available, and participant contacted by the study team either by telephone or My Chart regarding clinically significant results that require intervention. If potassium levels are higher than 5.2 Meq/L, the study team contacts the participant or their alternate contact directly. For the intervention group, this is in addition to the finger-stick blood collection.

Behavioral: Dietary education program

Control group

NO INTERVENTION

Participants randomized to the control group continue to receive medical, dietary, and nutritional advice from their medical team as normal. The testing is the same testing as the intervention group and will be done at day 1, day 8, and day 15 of the study. They do not participate in the educational sessions during the study but will have the opportunity to participate in the program at no charge at the conclusion of the study.

Interventions

Dietary education program BEHAVIORAL

Jumpstart educational program: https://www.rochesterlifestylemedicine.com/about-community-jumpstart/

Also known as: Nutritional education program

Jumpstart Educational Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Subjects with CKD 3 and 4 (as determined by an estimated glomerular filtration rate of ≥ 15 ml/min but \< 60 ml/min for at least three months)
• Subjects with hypertension, defined as use of antihypertension medication:
• Lack of significant proteinuria ( subjects will have a 24 hour urine protein value of \< 500 mg or a spot protein to creatinine ratio of \< 0.5 or a microalbumin to creatinine ratio \< 300) within previous 3 months.
• Fluent in English language
• Able and willing to comply with the testing schedule and the meeting schedule of the Jumpstart
• Able and willing to comply with dietary advice of whole-food plant based diet given during the educational session
• Able and willing to give informed consent
• Must have computer/internet access to participate in virtual Zoom educational sessions (intervention group only)

You may not qualify if:

• Kidney disease requiring immunosuppressive therapy
• Diabetes mellitus
• Pregnancy
• Life expectancy \< 12 months
• History of solid organ transplant or anticipated solid organ transplant in next 2 months
• History of hyperkalemia: (two or more potassium levels ≥ 5.0 Meq/L or those requiring intervention for high potassium levels within the last six months)
• Subjects with malabsorptive syndromes
• Subjects with history of bariatric surgery or planned bariatric surgery in the next 2 months
• Subjects on warfarin
• Subjects with documented eating disorder at the time of consent
• Allergy or intolerance of a plant-based or plant-derived food (gluten, soy, etc.)
• Following a vegan diet in the six months prior to consent
• Major surgery within 60 days prior to consent

Sponsors & Collaborators

• University of Rochester: lead
• Rochester Lifestyle Medicine Institute: collaborator

Study Sites (2)

Clinical Research Center of the University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Hyperkalemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division of Nephrology

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: October 26, 2020
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

US (2)